ORIGINAL ARTICLE
Fast-Track Versus Standard Care in Laparoscopic High Anterior Resection: A Prospective Randomized-Controlled Trial Giulio M. Mari, MD, Andrea Costanzi, MD, Dario Maggioni, MSI, Matteo Origi, MD, Giovanni C. Ferrari, MD, Paolo De Martini, MD, Stefano De Carli, MD, and Raffaele Pugliese, MD
Abstract: The value of fast-track (FT) multimodal recovery programs in improving hospitalization of surgical patients has been widely proved. The application of FT protocols to laparoscopic colorectal surgery seems to maximize the effects of the minimally invasive approach. The objectives of this randomized-controlled trial are to compare the short-term outcomes (bowel function, return to oral nutrition, day of discharge, fatigue, time to resume normal activities, functional capabilities, and readmission rate) of patients undergoing elective laparoscopic high anterior resection (HAR) following either a FT or a standard program. The prospective randomized-controlled trial included 52 consecutive patients undergoing elective laparoscopic HAR. Group 1 was treated with a FT rehabilitation program, and group 2 was treated with a standard care (SC) program. Patients were interviewed 14 and 30 days postoperatively. One patient in each group was excluded from the study. Mean hospital stay, time of first bowel movement, and bowel function resumption were significantly shorter in the FT group (P < 0.05). Patients in the FT group referred more pain in day 0 versus patients in the SC group (P < 0.05) even though the difference disappeared from day 1. Fatigue was significantly reduced at day 14 in the FT group compared with the SC group (P < 0.01). Similarly, ability to resume the normal preoperative attitude (walking stairs, cooking, housekeeping, shopping, and walking outdoors) was significantly better at day 14 in the FT group (P < 0.005). There was no significant difference between the 2 groups at day 30 for the same parameters. There were no readmissions in both the groups and no need for consultations from general practitioners. FT multimodal program is a safe approach effective on postoperative short-term outcome significantly reducing hospital stay. Early postoperative pain control needs to be optimized. Key Words: fast-track, colorectal surgery, laparoscopy, high anterior resection, left hemicolectomy, prospective controlled randomized study
(Surg Laparosc Endosc Percutan Tech 2014;24:118–121)
F
ast-track (FT) programs applied to colorectal surgery are nowadays well known to be feasible and effective.1,2 Hospital stay is demonstrated to be significantly shorter when surgery is supported by perioperative enhanced programs.3 Complication rate is reported to be equal or in some cases even lower compared with standard care (SC) programs.
Received for publication November 30, 2012; accepted July 14, 2013. From the Chirurgia Generale e Videolaparoscopica. Ospedale Niguarda—Ca` Granda, Milano, Italy. The authors declare no conflicts of interest. Reprints: Giulio M. Mari, MD, Department of Medicine, Desio Hospital, Desio, via Mazzini 1, zip code 20033, Monza e Brianza, Italy (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
118 | www.surgical-laparoscopy.com
Moreover, in abdominal surgery, FT has been applied to almost all different kinds of procedures showing good result in terms of length of hospital stay, bowel function recovery, oral intake resumption, complication rate, and patient’s satisfaction. FT programs’ effectiveness in colorectal surgery was evaluated and compared with SC programs by many authors.4–6 Laparoscopic colorectal surgery turned out to be a main factor among all the aspects composing an enhanced recovery program. Most part of the evidence on FT colonic surgery is still described retrospectively even if prospective controlled randomized trials are now becoming available.7 The aim of this study was to verify the safety and effectiveness of the FT approach in a quite elderly population of patients and to compare prospectively the short-term outcomes in 2 groups of patients undergoing elective total laparoscopic colorectal surgery treated with a FT program and SC program.
MATERIALS AND METHODS Inclusion criteria in our randomized-controlled trial were: total laparoscopic high anterior resection (HAR), American Society of Anaestesiologists physical status (ASA) score assignment from 1 to 3, age between 18 to 85, body mass index (BMI) < 30, and no intestinal diversion. From January to October 2012, of the 64 patients given the indication for HAR for benign or oncologic disease, 52 patients satisfied the inclusion criteria. Randomization was made en bloc with sealed envelopes. The 2 groups were homogeneous for age, BMI, and diagnosis. M:F ratio was 25:27, median age was 66 (29 to 83), and medium BMI was 24.7 ± 3.91. Thirty-six patients had adenocarcinoma of the left colon, and 16 patients diverticular disease. Thirty-five patients were classified with an ASA score of 2, 15 patients with an ASA score of 2, and 1 patient with an ASA score of 3. Both the FT and the SC groups comprised 26 patients. Five patients had hypertension (3 men, 2 women), 3 patients had liver metastasis (2 men, 1 woman), 2 patients had a BMI close to 30 (1 man, 1 woman), 1 man had multinodular struma, and 1 woman had dyslipidaemia. All 52 patients underwent HAR with a transanal anastomosis according to Knight-Griffen, ligation of the inferior mesenteric artery at the origin, and mobilization of the splenic flexure. Three surgeons performed all the 52 surgical procedures.
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
In 1 patient of the FT group, HAR was associated with laparoscopic cholecystectomy. Two patients were excluded (1 from each group) for conversion because of adhesions and intestinal diversion. Fifty patients completed the study (Fig. 1). The FT program requested preoperative maltodestrine drink intake together with no preoperative fasting, early postoperative oral feeding and mobilization, restriction of intraoperative fluid administration, opioid-free postoperative analgesia, and no nasogastric tube placement. The 2 protocols are described in Table 1. All patients attended a daily interview about bowel function, first passage of flatus and stool, walking capability, first solid meal intake, and pain perception during recovery. Discharge criteria were intake of 3 solid meals together with the passage of stool. Blood loss and duration of surgery were intraoperatively collected. All patients had prophylactic antibiotics at induction. Intraoperative hypothermia was prevented by routinely monitoring the patient’s temperature and utilizing an airwarming system, along with intravenous fluid warmers. Pain perception was collected on day 0 at 1-3-5 hours after return to the surgical ward and then daily until discharge and on day 14 and 30. 1 to 10 VAS pain scale was used. A structured interview-based assessment was conducted preoperatively on day 14 and 30 postoperatively. Interviews were conducted by phone. Fatigue was measured on a verbal scale (0 = no fatigue, 1 = mild, 2 = moderate, and 3 = severe fatigue). Activity of daily living was measured as the need for personal care (BADL) and as the ability to perform physical activities (IADL). BADL was scored as the need for care according to mobility, personal hygiene, dressing, eating, sensory functions, overall activity, urinary and gastrointestinal functions, social integration, and psychiatric support on a 4-point scale (0 = no need for care, 4 = total compensated care, maximum score 36 describing total dependency of care). IADL was assessed by means of being able to walk outdoors, walking stairs, cooking, housekeeping, car driving, and shopping on a 0 to 1 scale (0 = no, 1 = yes). Consultations from the general practitioners and unplanned contacts at the outpatient clinic were assessed within the first month in terms of number of visits and reasons. Readmissions during the first month were recorded. All patients completed the follow-up. This study has been reviewed and approved by the central audit commission.
Fast-Track Versus Standard Care
RESULTS There were no statistically significant differences at the time of surgery (P < 0.51), diuresis (P < 0.08), and blood loss (P < 0.782) in the 2 groups as shown in Table 2. All surgeons described intraoperatively nondistended bowel loops in patients who received maltodestrine before surgery. In the postoperative period, FT patients returned faster to a normal bowel function. Passage of flatus and stool and return to a solid meal happened statistically earlier in the FT group compared with the patients in the standard group. First bowel movement happened at day 0.3 ± 0.647 in FT versus 1.73 ± 0.483 SC (P < 0.005), first flatus happened at day 0.9 ± 0.78 in FT versus 2.1 ± 0.94 SC (P < 0.005), and passage of stool happened at day 1.6 ± 0.966 in FT versus 5 ± 1.79 in SC (P < 0.005). Solid diet was tolerated at day 1.2 ± 0.421 in FT versus 3.81 ± 0.982 in SC (P < 0.005). FT patients could walk at least 60 meters in day 1.3 ± 0.82 versus 3.55 ± 0.483 in SC (P < 0.005). Day of discharge was 4.7 ± 2.4 in FT versus day 7.65 ± 2.4 SC (P < 0.005). One FT patient was discharged on day 14 because of respiratory distress occurring on day 3 after surgery that required diuretic and antibiotic therapy for 7 days. Pain perception at 1 hour after surgery was significantly higher in FT (P < 0.05), the difference became nonsignificant after 5 hours. From day 1, FT patients referred less pain as compared with SC patients, even nonsignificantly. Fatigue was significantly reduced at day 14 in FT patients compared with SC patients (P < 0.01) throughout the whole study period. Similarly, ability to resume the normal preoperative attitude (walking stairs, cooking, housekeeping, shopping, and walking outdoors) was significantly less reduced at day 14 in FT (P < 0.005). There was no statistically significant difference between the 2 groups at days 30 for the same parameters. FT patients referred a higher pain perception in the immediate postoperative time (up to 5 h from surgery) than the SC patients (P < 0.05). Five hours after surgery, there was no statistically significant difference in pain perception between the 2 groups, and from day 1 FT patients referred less pain than SC patients (P < 0.05). There were no readmissions and no major complications in both the groups. The above-mentioned medical complication in the FT group lead to delayed discharge. No anastomotic leaks were reported.
FIGURE 1. Flow chart of randomization. r
2014 Lippincott Williams & Wilkins
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Mari et al
Volume 24, Number 2, April 2014
TABLE 1. Programs’ Descriptions
FT Preoperative period Alimentation Day before surgery Lunch Dinner Bowel preparation Surgery Perioperative devices Nasogastric tube Central line Bladder catheter Fluid administration (mL/kg/h) Analgesia Antibiotic therapy
SC
Fiber-free diet for 4-5 d preoperatively
Fiber-free diet for 4-5 d preoperatively
Free diet Maltodestrine drinks Clisma fleet 100 mL 2 the evening before surgery
Free diet Fasting (1000 glucosalina) Osmotic laxative
Removed after surgery No Yes 10 Paracetamol 1 g 4 wound infiltration with naropine 7.5% 2 fL
Yes Yes Yes 15 Morfyn 3 fL + NSAID 2 fL + Metoclopramyd 1 fL. In continuous infusion Short term: cephazoline + metronidazole
Short term: cephazoline 2 g IV + metronidazole
Postoperative period Mobilization
5 h after surgery (patient sits down), free walking from day 1 5 h after surgery (oral semi-solid diet)
Oral intake Fluid administration Day 0
100 mL/h for 20 h in continuous parenteral infusion. Protein-loaded drink 1 L (Protifar) Removal of bladder catheter Semi-solid diet/fiber-free diet Mobilization, at least 100 m Paracetamol 1 g 4 Protifar 1 L Fiber-free diet Paracetamol 1 g 4 Increased mobilization At day 2 till fulfillment of discharged criteria
Day 1
Day 2 Day 3 Day 4 Day 5
Day 1 Day 2 100 mL/h for 48 h in continuous parenteral infusion Removal of nasogastric tube Parenteral fluid administration Mobilization Stop opioid (NSAID if necessary) Parenteral fluid administration Removal of bladder catheter Mobilization, fluid intake Semi-solid diet Mobilization Fiber-free diet Mobilization Fiber-free diet, mobilization till fulfillment of discharged criteria
FT indicates fast-track; NSAID, non steroidal anti-inflammatory drugs; SC, standard care.
DISCUSSION Recent developments in the perioperative management of patients undergoing colorectal surgery have shown how reduction of surgical stress significantly improves patients’ outcomes.8 FT is a clinical and surgical approach that aims to make both minor and major surgical procedures physically bearable. Changes in the use of surgical devices and intraoperative, nutritional, and rehabilitative behaviors brought new statements in general surgery.9 In particular, FT programs applied TABLE 2. Intraoperative Parameters Detected
FT
SC
Duration of surgery 235.5 ± 81.39 215.45 ± 53.55 Urinary output (mL) 649 ± 422.73 552.73 ± 210.05 Blood loss (mL) 115.2 ± 14.6 104.5 ± 11.5 FT indicates fast-track; SC, standard care.
120 | www.surgical-laparoscopy.com
P < 0.51 < 0.08 < 0.782
to colorectal surgery is known now to be feasible and safe even when applied to a quite elderly population.10 Laparoscopic colonic surgery is considered to be an effective approach to optimize postoperative management.11,12 FT protocols have demonstrated advantages after open surgery, but their impact on recovery after laparoscopic HAR is yet to be clearly defined.13 FT programs seem to enhance the potential effect of the laparoscopic technique on surgical stress induced to patients undergoing colorectal surgery.7 Shorter hospitalization, faster return to bowel function and oral nutrition, and patient satisfaction can actually be improved by FT programs.14 FT applied to laparoscopy significantly reduced hospital stay by almost 3 days in our study, suggesting that laparoscopy by itself cannot be considered a really minimally invasive approach if not supported by a perioperative enhanced recovery program. Bowel function recovery was positively affected (edited) by early postoperative oral nutrition and no bowel r
2014 Lippincott Williams & Wilkins
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
preoperative preparation. FT patients could pass flatus and stool significantly earlier than SC patients, thus achieving the discharge criteria sooner. FT significantly improved the return to normal daily activities. From our results, patients’ performance status at day 14 was better in the FT group; meanwhile, no significant difference was noted in readmission rates and morbidity between the groups. At day 30 from surgery, the differences in the 2 groups disappeared. The major evidence of FT program effectiveness can be actually noted in the immediate postoperative period, in terms of faster return to normal daily activities. Complication rate seemed to be affected more by surgery than by perioperative management, showing a very low rate in both the groups. In fact, no major complication occurred in both the groups. Avoidance of complication is the most important factor to achieve acceptable outcomes and FT did not negatively affect the complication rate. It is specifically the category of patients without complications that will benefit the most from strict adherence to FT programs. Pain perception on day 0 after surgery still remains an open issue when approached with the FT protocol we used. Implementation of morphine-free analgesia has to be optimized to obtain a better pain relief in the immediate postoperative period. From day 1, FT patients referred to less pain than SC, suggesting that pain perception reduces, as bowel function and patients’ general conditions improve. The FT program requires patient’s involvement to achieve the aimed targets; sharing the responsibilities of such a clinical program with patients has been one of the most appreciated aspects of implementing FT.15
CONCLUSIONS FT multimodal program is a safe approach, effective on postoperative short-term outcomes, significantly reducing hospital stay. Neither readmission rate nor incidence of short-term complications in patients within the FT group were significantly higher compared with patients in the SC group. Early postoperative opioid-free pain control still remains a critical issue. REFERENCES 1. Kehlet H. Fast-track colonic surgery: status and perspectives. Recent Results Cancer Res. 2005;165:8–13.
r
2014 Lippincott Williams & Wilkins
Fast-Track Versus Standard Care
2. Schwenk W, Kehlet H. Meta-analysis of short-term outcomes after laparoscopic resection for colorectal cancer (Br J Surg 2004; 91: 1111-1124). Br J Surg. 2004;91:1653–1654. 3. Bosio RM, Smith BM, Aybar PS, et al. Implementation of laparoscopic colectomy with fast-track care in an academic medical center: benefits of a fully ascended learning curve and specialty expertise. Am J Surg. 2007;193:413–415; discussion 415-6. 4. Jakobsen DH, Sonne E, Andreasen J, et al. Convalescence after colonic surgery with fast-track versus conventional care. Colorectal Dis. 2006;8:683–687. 5. Nygren J, Hausel J, Kehlet H, et al. A comparison in five european centres of case mix, clinical management and outcomes following either conventional or fast-track perioperative care in colorectal surgery. Clin Nutr. 2005;24:455–461. 6. Reza MM, Blasco JA, Andradas E, et al. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006;93:921–928. 7. Lv L, Shao YF, Zhou YB. The enhanced recovery after surgery (ERAS) pathway for patients undergoing colorectal surgery: an update of meta-analysis of randomized controlled trials. Int J Colorectal Dis. 2012;27:1549–1554. 8. Yang D, He W, Zhang S, et al. Fast-track surgery improves postoperative clinical recovery and immunity after elective surgery for colorectal carcinoma: randomized controlled clinical trial. World J Surg. 2012;36:1874–1880. 9. Van Bree SH, Vlug MS, Bemelman WA, et al. Faster recovery of gastrointestinal transit after laparoscopy and fasttrack care in patients undergoing colonic surgery. Gastroenterology. 2011;141:872e1-4–880e1-4. 10. Wang Q, Suo J, Jiang J, et al. Effectiveness of fast-track rehabilitation vs conventional care in laparoscopic colorectal resection for elderly patients: a randomized trial. Colorectal Dis. 2012;14:1009–1013. 11. Tsilimparis N, Haase O, Wendling P, et al. Laparoscopic “fasttrack” sigmoidectomy for diverticulitis disease in Germany. Results of a prospective quality assurance program. Dtsch Med Wochenschr. 2010;135:1743–1748, 2010 Sep 1. 12. Feroci F, Kro¨ning KC, Lenzi E, et al. Laparoscopy within a fast-track program enhances the short-term results after elective surgery for resectable colorectal cancer. Surg Endosc. 2011;25:2919–2925. 13. Tsikitis VL, Holubar SD, Dozois EJ, et al. Advantages of fast track recovery after laparoscopic right hemicolectomy for colon cancer. Surgical Endosc. 2010;24:1911–1916. 14. Ionescu D, Iancu C, Ion D, et al. Implementing fast-track protocol for colorectal surgery: a prospective randomized clinical trial. World J Surg. 2009;33:2433–2438. 15. Feroci F, Lenzi E, Baraghini M, et al. Fast-track colorectal surgery: protocol adherence influences postoperative outcomes. Int J Colorectal Dis. 2013;28:103–109.
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Fast-Track Versus Standard Care in Laparoscopic High Anterior Resection: A Prospective Randomized-Controlled Trial Giulio M. Mari, MD, Andrea Costanzi, MD, Dario Maggioni, MSI, Matteo Origi, MD, Giovanni C. Ferrari, MD, Paolo De Martini, MD, Stefano De Carli, MD, and Raffaele Pugliese, MD
Abstract: The value of fast-track (FT) multimodal recovery programs in improving hospitalization of surgical patients has been widely proved. The application of FT protocols to laparoscopic colorectal surgery seems to maximize the effects of the minimally invasive approach. The objectives of this randomized-controlled trial are to compare the short-term outcomes (bowel function, return to oral nutrition, day of discharge, fatigue, time to resume normal activities, functional capabilities, and readmission rate) of patients undergoing elective laparoscopic high anterior resection (HAR) following either a FT or a standard program. The prospective randomized-controlled trial included 52 consecutive patients undergoing elective laparoscopic HAR. Group 1 was treated with a FT rehabilitation program, and group 2 was treated with a standard care (SC) program. Patients were interviewed 14 and 30 days postoperatively. One patient in each group was excluded from the study. Mean hospital stay, time of first bowel movement, and bowel function resumption were significantly shorter in the FT group (P < 0.05). Patients in the FT group referred more pain in day 0 versus patients in the SC group (P < 0.05) even though the difference disappeared from day 1. Fatigue was significantly reduced at day 14 in the FT group compared with the SC group (P < 0.01). Similarly, ability to resume the normal preoperative attitude (walking stairs, cooking, housekeeping, shopping, and walking outdoors) was significantly better at day 14 in the FT group (P < 0.005). There was no significant difference between the 2 groups at day 30 for the same parameters. There were no readmissions in both the groups and no need for consultations from general practitioners. FT multimodal program is a safe approach effective on postoperative short-term outcome significantly reducing hospital stay. Early postoperative pain control needs to be optimized. Key Words: fast-track, colorectal surgery, laparoscopy, high anterior resection, left hemicolectomy, prospective controlled randomized study
(Surg Laparosc Endosc Percutan Tech 2014;24:118–121)
F
ast-track (FT) programs applied to colorectal surgery are nowadays well known to be feasible and effective.1,2 Hospital stay is demonstrated to be significantly shorter when surgery is supported by perioperative enhanced programs.3 Complication rate is reported to be equal or in some cases even lower compared with standard care (SC) programs.
Received for publication November 30, 2012; accepted July 14, 2013. From the Chirurgia Generale e Videolaparoscopica. Ospedale Niguarda—Ca` Granda, Milano, Italy. The authors declare no conflicts of interest. Reprints: Giulio M. Mari, MD, Department of Medicine, Desio Hospital, Desio, via Mazzini 1, zip code 20033, Monza e Brianza, Italy (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
118 | www.surgical-laparoscopy.com
Moreover, in abdominal surgery, FT has been applied to almost all different kinds of procedures showing good result in terms of length of hospital stay, bowel function recovery, oral intake resumption, complication rate, and patient’s satisfaction. FT programs’ effectiveness in colorectal surgery was evaluated and compared with SC programs by many authors.4–6 Laparoscopic colorectal surgery turned out to be a main factor among all the aspects composing an enhanced recovery program. Most part of the evidence on FT colonic surgery is still described retrospectively even if prospective controlled randomized trials are now becoming available.7 The aim of this study was to verify the safety and effectiveness of the FT approach in a quite elderly population of patients and to compare prospectively the short-term outcomes in 2 groups of patients undergoing elective total laparoscopic colorectal surgery treated with a FT program and SC program.
MATERIALS AND METHODS Inclusion criteria in our randomized-controlled trial were: total laparoscopic high anterior resection (HAR), American Society of Anaestesiologists physical status (ASA) score assignment from 1 to 3, age between 18 to 85, body mass index (BMI) < 30, and no intestinal diversion. From January to October 2012, of the 64 patients given the indication for HAR for benign or oncologic disease, 52 patients satisfied the inclusion criteria. Randomization was made en bloc with sealed envelopes. The 2 groups were homogeneous for age, BMI, and diagnosis. M:F ratio was 25:27, median age was 66 (29 to 83), and medium BMI was 24.7 ± 3.91. Thirty-six patients had adenocarcinoma of the left colon, and 16 patients diverticular disease. Thirty-five patients were classified with an ASA score of 2, 15 patients with an ASA score of 2, and 1 patient with an ASA score of 3. Both the FT and the SC groups comprised 26 patients. Five patients had hypertension (3 men, 2 women), 3 patients had liver metastasis (2 men, 1 woman), 2 patients had a BMI close to 30 (1 man, 1 woman), 1 man had multinodular struma, and 1 woman had dyslipidaemia. All 52 patients underwent HAR with a transanal anastomosis according to Knight-Griffen, ligation of the inferior mesenteric artery at the origin, and mobilization of the splenic flexure. Three surgeons performed all the 52 surgical procedures.
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
In 1 patient of the FT group, HAR was associated with laparoscopic cholecystectomy. Two patients were excluded (1 from each group) for conversion because of adhesions and intestinal diversion. Fifty patients completed the study (Fig. 1). The FT program requested preoperative maltodestrine drink intake together with no preoperative fasting, early postoperative oral feeding and mobilization, restriction of intraoperative fluid administration, opioid-free postoperative analgesia, and no nasogastric tube placement. The 2 protocols are described in Table 1. All patients attended a daily interview about bowel function, first passage of flatus and stool, walking capability, first solid meal intake, and pain perception during recovery. Discharge criteria were intake of 3 solid meals together with the passage of stool. Blood loss and duration of surgery were intraoperatively collected. All patients had prophylactic antibiotics at induction. Intraoperative hypothermia was prevented by routinely monitoring the patient’s temperature and utilizing an airwarming system, along with intravenous fluid warmers. Pain perception was collected on day 0 at 1-3-5 hours after return to the surgical ward and then daily until discharge and on day 14 and 30. 1 to 10 VAS pain scale was used. A structured interview-based assessment was conducted preoperatively on day 14 and 30 postoperatively. Interviews were conducted by phone. Fatigue was measured on a verbal scale (0 = no fatigue, 1 = mild, 2 = moderate, and 3 = severe fatigue). Activity of daily living was measured as the need for personal care (BADL) and as the ability to perform physical activities (IADL). BADL was scored as the need for care according to mobility, personal hygiene, dressing, eating, sensory functions, overall activity, urinary and gastrointestinal functions, social integration, and psychiatric support on a 4-point scale (0 = no need for care, 4 = total compensated care, maximum score 36 describing total dependency of care). IADL was assessed by means of being able to walk outdoors, walking stairs, cooking, housekeeping, car driving, and shopping on a 0 to 1 scale (0 = no, 1 = yes). Consultations from the general practitioners and unplanned contacts at the outpatient clinic were assessed within the first month in terms of number of visits and reasons. Readmissions during the first month were recorded. All patients completed the follow-up. This study has been reviewed and approved by the central audit commission.
Fast-Track Versus Standard Care
RESULTS There were no statistically significant differences at the time of surgery (P < 0.51), diuresis (P < 0.08), and blood loss (P < 0.782) in the 2 groups as shown in Table 2. All surgeons described intraoperatively nondistended bowel loops in patients who received maltodestrine before surgery. In the postoperative period, FT patients returned faster to a normal bowel function. Passage of flatus and stool and return to a solid meal happened statistically earlier in the FT group compared with the patients in the standard group. First bowel movement happened at day 0.3 ± 0.647 in FT versus 1.73 ± 0.483 SC (P < 0.005), first flatus happened at day 0.9 ± 0.78 in FT versus 2.1 ± 0.94 SC (P < 0.005), and passage of stool happened at day 1.6 ± 0.966 in FT versus 5 ± 1.79 in SC (P < 0.005). Solid diet was tolerated at day 1.2 ± 0.421 in FT versus 3.81 ± 0.982 in SC (P < 0.005). FT patients could walk at least 60 meters in day 1.3 ± 0.82 versus 3.55 ± 0.483 in SC (P < 0.005). Day of discharge was 4.7 ± 2.4 in FT versus day 7.65 ± 2.4 SC (P < 0.005). One FT patient was discharged on day 14 because of respiratory distress occurring on day 3 after surgery that required diuretic and antibiotic therapy for 7 days. Pain perception at 1 hour after surgery was significantly higher in FT (P < 0.05), the difference became nonsignificant after 5 hours. From day 1, FT patients referred less pain as compared with SC patients, even nonsignificantly. Fatigue was significantly reduced at day 14 in FT patients compared with SC patients (P < 0.01) throughout the whole study period. Similarly, ability to resume the normal preoperative attitude (walking stairs, cooking, housekeeping, shopping, and walking outdoors) was significantly less reduced at day 14 in FT (P < 0.005). There was no statistically significant difference between the 2 groups at days 30 for the same parameters. FT patients referred a higher pain perception in the immediate postoperative time (up to 5 h from surgery) than the SC patients (P < 0.05). Five hours after surgery, there was no statistically significant difference in pain perception between the 2 groups, and from day 1 FT patients referred less pain than SC patients (P < 0.05). There were no readmissions and no major complications in both the groups. The above-mentioned medical complication in the FT group lead to delayed discharge. No anastomotic leaks were reported.
FIGURE 1. Flow chart of randomization. r
2014 Lippincott Williams & Wilkins
www.surgical-laparoscopy.com |
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Surg Laparosc Endosc Percutan Tech
Mari et al
Volume 24, Number 2, April 2014
TABLE 1. Programs’ Descriptions
FT Preoperative period Alimentation Day before surgery Lunch Dinner Bowel preparation Surgery Perioperative devices Nasogastric tube Central line Bladder catheter Fluid administration (mL/kg/h) Analgesia Antibiotic therapy
SC
Fiber-free diet for 4-5 d preoperatively
Fiber-free diet for 4-5 d preoperatively
Free diet Maltodestrine drinks Clisma fleet 100 mL 2 the evening before surgery
Free diet Fasting (1000 glucosalina) Osmotic laxative
Removed after surgery No Yes 10 Paracetamol 1 g 4 wound infiltration with naropine 7.5% 2 fL
Yes Yes Yes 15 Morfyn 3 fL + NSAID 2 fL + Metoclopramyd 1 fL. In continuous infusion Short term: cephazoline + metronidazole
Short term: cephazoline 2 g IV + metronidazole
Postoperative period Mobilization
5 h after surgery (patient sits down), free walking from day 1 5 h after surgery (oral semi-solid diet)
Oral intake Fluid administration Day 0
100 mL/h for 20 h in continuous parenteral infusion. Protein-loaded drink 1 L (Protifar) Removal of bladder catheter Semi-solid diet/fiber-free diet Mobilization, at least 100 m Paracetamol 1 g 4 Protifar 1 L Fiber-free diet Paracetamol 1 g 4 Increased mobilization At day 2 till fulfillment of discharged criteria
Day 1
Day 2 Day 3 Day 4 Day 5
Day 1 Day 2 100 mL/h for 48 h in continuous parenteral infusion Removal of nasogastric tube Parenteral fluid administration Mobilization Stop opioid (NSAID if necessary) Parenteral fluid administration Removal of bladder catheter Mobilization, fluid intake Semi-solid diet Mobilization Fiber-free diet Mobilization Fiber-free diet, mobilization till fulfillment of discharged criteria
FT indicates fast-track; NSAID, non steroidal anti-inflammatory drugs; SC, standard care.
DISCUSSION Recent developments in the perioperative management of patients undergoing colorectal surgery have shown how reduction of surgical stress significantly improves patients’ outcomes.8 FT is a clinical and surgical approach that aims to make both minor and major surgical procedures physically bearable. Changes in the use of surgical devices and intraoperative, nutritional, and rehabilitative behaviors brought new statements in general surgery.9 In particular, FT programs applied TABLE 2. Intraoperative Parameters Detected
FT
SC
Duration of surgery 235.5 ± 81.39 215.45 ± 53.55 Urinary output (mL) 649 ± 422.73 552.73 ± 210.05 Blood loss (mL) 115.2 ± 14.6 104.5 ± 11.5 FT indicates fast-track; SC, standard care.
120 | www.surgical-laparoscopy.com
P < 0.51 < 0.08 < 0.782
to colorectal surgery is known now to be feasible and safe even when applied to a quite elderly population.10 Laparoscopic colonic surgery is considered to be an effective approach to optimize postoperative management.11,12 FT protocols have demonstrated advantages after open surgery, but their impact on recovery after laparoscopic HAR is yet to be clearly defined.13 FT programs seem to enhance the potential effect of the laparoscopic technique on surgical stress induced to patients undergoing colorectal surgery.7 Shorter hospitalization, faster return to bowel function and oral nutrition, and patient satisfaction can actually be improved by FT programs.14 FT applied to laparoscopy significantly reduced hospital stay by almost 3 days in our study, suggesting that laparoscopy by itself cannot be considered a really minimally invasive approach if not supported by a perioperative enhanced recovery program. Bowel function recovery was positively affected (edited) by early postoperative oral nutrition and no bowel r
2014 Lippincott Williams & Wilkins
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 2, April 2014
preoperative preparation. FT patients could pass flatus and stool significantly earlier than SC patients, thus achieving the discharge criteria sooner. FT significantly improved the return to normal daily activities. From our results, patients’ performance status at day 14 was better in the FT group; meanwhile, no significant difference was noted in readmission rates and morbidity between the groups. At day 30 from surgery, the differences in the 2 groups disappeared. The major evidence of FT program effectiveness can be actually noted in the immediate postoperative period, in terms of faster return to normal daily activities. Complication rate seemed to be affected more by surgery than by perioperative management, showing a very low rate in both the groups. In fact, no major complication occurred in both the groups. Avoidance of complication is the most important factor to achieve acceptable outcomes and FT did not negatively affect the complication rate. It is specifically the category of patients without complications that will benefit the most from strict adherence to FT programs. Pain perception on day 0 after surgery still remains an open issue when approached with the FT protocol we used. Implementation of morphine-free analgesia has to be optimized to obtain a better pain relief in the immediate postoperative period. From day 1, FT patients referred to less pain than SC, suggesting that pain perception reduces, as bowel function and patients’ general conditions improve. The FT program requires patient’s involvement to achieve the aimed targets; sharing the responsibilities of such a clinical program with patients has been one of the most appreciated aspects of implementing FT.15
CONCLUSIONS FT multimodal program is a safe approach, effective on postoperative short-term outcomes, significantly reducing hospital stay. Neither readmission rate nor incidence of short-term complications in patients within the FT group were significantly higher compared with patients in the SC group. Early postoperative opioid-free pain control still remains a critical issue. REFERENCES 1. Kehlet H. Fast-track colonic surgery: status and perspectives. Recent Results Cancer Res. 2005;165:8–13.
r
2014 Lippincott Williams & Wilkins
Fast-Track Versus Standard Care
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